Kornimate/medical-research-clean huggingface dataset:
the safety and feasibility of transoral endoscopic thyroidectomy vestibular approach

Conditions: Thyroid Diseases; Surgery

Summary: this is a single center, prospective case series designed to assess the safety and feasibility of toetva in a small cohort of patients at university health network toronto. included patients will undergo a toetva-procedure in stead of the standard open surgical procedure.

type of study this is a single center, prospective case series sample size since this is a feasibility study we will first include 15 patients. if we find the toetva a safe and feasible approach, we will perform the same study in more patients using the results of this study for a power size calculation. study population patients (\> 18 years) undergoing (para)thyroid surgery for the indication of a benign or indeterminate thyroid nodule, well differentiated papillary thyroid carcinoma, well-controlled grave's disease or a parathyroid adenoma. study design this is a single center, prospective case series designed to assess the safety and feasibility of toetva in a small cohort of patients at university health network toronto. included patients will undergo a toetva-procedure in stead of the standard open surgical procedure. study intervention the study intervention in this study is the toetva-procedure. this is an transoral endoscopic thyroidectomy vestibular approach. primary objective the study objective is to assess the safety and feasibility of this procedure in a small cohort of patients at university health network toronto, ontario. endpoints of the study the main study endpoints consist of 1. surgical outcomes: rate of post-operative recurrent laryngeal nerve palsy, rate of post-operative hypocalcemia, and rate of neck incision (conversion to open), oral infections, neck infection, hematoma, seroma, subcutaneous emphysema, gas-induced embolism, surgical time, and length of stay. 2. quality of life - eortc thyroid specific health related quality of life these endpoints will be compared to historical age/indication controls for analysis.

Eligibility criteria:
inclusion criteria: - patients needing surgery for: benign or indeterminate nodule less than 6 cm in size or; t1 well differentiated papillary carcinoma less than 2 cm in size or; well-controlled grave's disease or; parathyroid adenoma. * total thyroid size is 7-8 cm (no more than 10 cm) * their age is ≥18 years and ≤80 years * able to give written consent exclusion criteria: * - history of neck surgery or neck radiotherapy * recurrent thyroid disease * lymph node metastases * presence of intraoral infections * presence of extrathyroidal or substernal extensions * smoking * morbid obesity * contra-indication to general anesthesia with nasotracheal intubation * previous mediastinal surgery * any anatomical anomaly that in the opinion of the investigator may render the intervention more difficult (ex. variations in the structure of the platysmas muscle) * any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure

Keywords: toetva transoral endoscopic thyroidectomy vestibular approach
postoperative delirium after total knee arthroplasty under regional anesthesia

Conditions: Postoperative Delirium

Summary: postoperative delirium after total knee replacement surgery has been related to significant morbidity and mortality among high risk patients. anesthetic care might play a role in the development of postoperative delirium. the purpose of this study is to compare the incidence of postoperative delirium between different intraoperative sedation regimen. delirium assessment using standardized screening tools will be done every 8 hours after surgery.

* in this randomized controlled trial, the investigator will compare the incidence of postoperative delirium after total knee arthroplasty between 3 intraoperative sedation regimens including (1) propofol-fentanyl (2) dexmedetomidine -fentanyl (3) fentanyl alone * anesthesia techniques include spinal anesthesia and adductor canal block for postoperative analgesia. sedation will be provide per group assignment. * after performance of regional anesthesia, sedation protocols will be used as followed: (1) target-controlled infusion of propofol to achieve moaa/s of 3-4 (2) incremental titration of dexmedetomidine to achieve moaa/s of 3-4 (3) supplemental fentanyl for anxiolysis. * delirium will be screened by trained physicians, registered nurses every 8 hours postoperatively with validated thai-version cam-icu (confusion assessment method-intensive care unit) until patient discharge. * serum interleukins (il-1, il-6) tumor necrosis factor-alpha and s100b protein from preoperative period will be compared with serum from postoperative period between delirium and non-delirium group. the level of serum biomarkers will be acquired in a 6-hour interval for 5 measurement points during the first postoperative day in the first 12 participants. the subsequent participants will have 1 measurement of serum biomarker during the first postoperative day. * genetic profile for apolipoproteine genotype will be acquired and compared between delirium and non-delirium group.

Eligibility criteria:
inclusion criteria: * age 65 year or older * scheduled for elective primary total knee arthroplasty exclusion criteria: * contraindication for spinal anesthesia * contraindication for adductor canal block * allergy to fentanyl or propofol or dexmedetomidine or bupivacaine * cognitive impairment * nsqip database risk calculator \> 10% overall complication * unable to communicate in thai language * significant visual and hearing impairment

Keywords: postoperative delirium total knee arthroplasty propofol dexmedetomidine fentanyl inflammatory response interleukins cam-icu
acyclovir therapy for genital herpes ulcers in hiv negative african women

Conditions: Ulcers of Female Genital Organs

Summary: this is a prospective study to evaluate the pharmacokinetics, clinical and virologic response to acyclovir episodic therapy for genital herpes ulcers in hiv negative african women.

this is a two-part study designed to measure the area under the curve (auc) from a single dose of acyclovir 400mg in 60 african hiv-negative heterosexual women who have a history of genital ulcer disease (gud), are hsv-2 seropositive and hiv-1 seronegative. the study will also examine the time to healing of genital lesion and duration of hsv shedding from gud among 90 hiv negative african women who have a history of gud and are herpes simplex virus (hsv)-2 seropositive and hiv-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir or matching placebo.

Eligibility criteria:
inclusion criteria: * hiv negative as determined by concordant rapid testing * hsv-2 seropositive (focus herpeselect eia \>3.4) * at least one prior occurrence of gud * 18 to 50 years of age exclusion criteria: * current use, or use within the past 7 days, of acyclovir, valacyclovir, or famciclovir * prior hypersensitivity and/or allergic reaction to acyclovir * use of probenecid, which prolongs renal excretion of acyclovir * current use, or use within the past 28 days, of an investigational agent * currently pregnant or nursing * currently plan to become pregnant during the next 3 months * currently consume, on average, more than 7 drinks of alcohol per week (for part i) * current use of more than 20 cigarettes daily (for part i) * any condition that in the opinion of the investigator will interfere with successful completion of all study procedures.

Keywords: pharmacokinetics herpes simplex virus genital herpes ulcers
registry for cardiogenic shock: utility and efficacy of device therapy

Conditions: Heart Failure; Cardiogenic Shock

Summary: the purpose of this study is to gather information on patients who have heart failure and are eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular assist device (vad) or 2) heart transplant. the study seeks to determine which patient populations benefit from heart transplant or ventricular assist device. this will allow to offer the state-of-the-art care to the patients in heart failure.

cardiogenic shock (cs) develops in the end stage of various etiologies of heart failure and continues to hold high mortality; ranging from 50 to 80%. expert consensus recommends use of more powerful mechanical circulatory support device (mcsd) in this patient population; however, scientific evidence has been anecdotal relying on mostly single-center small case series and, more fundamentally, because there is no unified definition to grade the severity of the highly heterogeneous condition cs. well-designed studies are warranted to precisely characterize the various "phenotypes" of cs as well as the role of mcsd in this condition with still excessive mortality. this multicenter registry will be the first multicenter large-scale registry focused on mechanical circulatory support (mcs) therapy for cs. the fundamental goal of rescue is to advance the understanding and application of mcsd in order to improve the persistently dismal survival of patients with cs with the following intents: 1. elucidate current indication and outcomes of mcsd use in cs. 2. redefine cs with better description of this disease entity, which will allow better prediction of outcomes, selection of treatment strategy, and comparison and design of studies. 3. facilitate the refinement of patient selection to maximize outcomes with current and new device options. 4. improve and expedite new device clinical trials by providing historical control data. 5. develop consensus "best practice" guidelines to improve clinical management by reducing short and long-term complications of mcsd therapy.

Eligibility criteria:
inclusion criteria: * adult patients who receive any mcsd including veno-arterial extracorporeal membrane oxygenation (va ecmo), surgical vad, and percutaneous vad, used to treat cs on or after 9/30/10. intraaortic balloon pumping (iabp) is not considered an mcsd in this registry. * adult patients who have signed informed consent. for patients who are too ill to give informed consent the health care proxy of the patient or next of kin will be approached for the informed consent. exclusion criteria: * patients younger than 18 years of age.

Keywords: mechanical circulatory support device (mcsd) ventricular assist device (vad)
the hand osteoarthritis exercise trial

Conditions: Hand Osteoarthritis

Summary: the purpose of this study is to evaluate the effect of a hand exercise intervention on function and osteoarthritis symptoms in persons with hand osteoarthritis .

hand osteoarthritis (oa) is one of the most prevalent musculoskeletal diseases in an adult population. the disease may have large influences on an individual's function, health related quality of life and participation in the society. in recently published clinical guidelines for management, non-pharmacological approaches are considered as core treatments. several studies have demonstrated that exercise may reduce pain and improve function in persons with knee oa, and a similar effect is suggested for hip oa. regarding effect of exercises in hand oa, available research results are limited, and randomised controlled trials (rct) of good quality are needed.

Eligibility criteria:
inclusion criteria: * the american college of rheumatology (acr) classification criteria for clinical hand osteoarthritis * fihoa ≥ 5 at pre-baseline * the persons must have a telephone exclusion criteria: * persons with cognitive dysfunction * persons who do not understand norwegian language * persons with inflammatory rheumatic diseases (e.g. rheumatoid arthritis, ankylosing spondylitis) or cancer * persons that have recently experienced severe trauma * persons that have recently gone through oa surgery or other major surgery
the effect of zinc on iron bioavailability from fortified extruded rice fortified with ferric pyrophosphate

Conditions: Iron Deficiency

Summary: investigation of iron bioavailability from extruded rice grains fortified with ferric pyrophosphate alone or in combination with different zinc compounds; ferrous sulfate serves as a reference.

ferric pyrophosphate (fepp) is a water-insoluble, food grade, iron compound widely used to fortify rice and other foods as it causes no organoleptic changes to the food vehicles. however, it is only of low absorption in man and its absorption can be influenced by a variety of compounds. the effect of co-fortification of rice with zno respectively znso4 on iron bioavailability in extruded rice fortified with fepp has never been investigated.

Eligibility criteria:
inclusion criteria: * female * serum ferritin level \< 15 µg/l * body weight \<65 kg * signed informed consent 4. body mass index in the range of 18.5 to 25 exclusion criteria: -
crocus sativus (saffron) and berberis vulgaris (barberry fruit) in metabolic syndrome

Conditions: Metabolic Syndrome; Hypercholesterolemia; Hypertriglyceridemia; Hyperglycemia

Summary: the metabolic syndrome is associated with increased risk of cardiovascular disease and diabetes mellitus. the age-adjusted prevalence of the metabolic syndrome in the united states is 34% for men and 35% for women. emerging alternative medicine worldwide led investigators to evaluate the efficacy of crocus sativus (saffron) and berberis vulgaris (barberry fruit) in treatment of metabolic syndrome. serum total cholesterol, serum ldl cholesterol, serum hdl cholesterol, serum triglyceride, fasting blood sugar and hematocrit measured before and after 45 days of treatment.

in a randomized, placebo controlled, single-blind , efficacy trial with three treatment arms the investigators randomly assigned 105 patients with metabolic syndrome to receive barberry juice, saffron juice or placebo tablet. the aim was to evaluate the efficacy of crocus sativus (saffron) and berberis vulgaris (barberry fruit) in treatment of metabolic syndrome. the metabolic syndrome (syndrome x, insulin resistance syndrome) consists of a constellation of metabolic abnormalities that confer increased risk of cardiovascular disease (cvd) and diabetes mellitus (dm). the major features of the metabolic syndrome include central obesity hypertriglyceridemia, low hdl cholesterol, hyperglycemia, and hypertension. based on data from the national health and nutrition examination survey (nhanes) iii, the age-adjusted prevalence of the metabolic syndrome in the united states is 34% for men and 35% for women. review of literature revealed anti-inflammatory, radical-scavenging, antioxidant, cytoprotective, beneficial cardiovascular and neural system effects for saffron, potential use for treatment of hypertension, tachycardia and some neuronal disorders, such as epilepsy and convulsion, antihypertensive and vasodilatory activities. barberry has promising and selective anti-cancer activities, beneficial effects in atherosclerosis, arthritis, coronary heart disease and hepatitis, hypotensive property and to promote immunity, prevention of insulin resistance and related diseases, neuroprotective, hypolipidemic and antioxidant properties for saffron in animal models.

Eligibility criteria:
inclusion criteria: * waist circumference of ≥ 94 cm (males) or ≥ 80 cm (females) plus any two of the following: * blood pressure ≥ 130/85 or taking antihypertensive medication, * fasting plasma glucose (fpg) \> 100 mg/dl, * serum triglycerides (tg) \> 150 mg/dl, * high-density lipoprotein (hdl) \< 40 mg/dl in men,and \< 50 mg/dl in women- exclusion criteria: * using insulin or glucose sensitizing medication * preexisting cardiovascular disease * psychiatric problems * non-compliance of patients * not presenting at times determined for treatment and evaluation

Keywords: metabolic syndrome hypercholesterolemia hypertriglyceridemia hyperglycemia
phase i imaging study evaluating dalotuzumab (mk0646) in combination with erlotinib for patients with non-small cell lung cancer (mk-0646-008)

Conditions: Carcinoma, Non-small Cell Lung

Summary: this study will use imaging to look at tumor response to erlotinib (part i) and the combination of erlotinib and dalotuzumab (part ii).


Eligibility criteria:
inclusion criteria: * patient has locally advanced or metastatic stage iiib/iv non-small cell lung cancer * patient has measurable disease * patient has accessible tumor and consents to undergo a tumor biopsy \[part ii only\] * patient is 18 years of age or older * patient has a performance status of 0-2 on ecog scale * women of childbearing potential have a negative pregnancy test * patients in part i must: 1. be a female non-smoker with non-squamous histology who has had one or two prior systemic chemotherapies or 2. have documented egfr mutation or egfr gene amplification, regardless of demographic or clinical characteristics, who have had no more than two prior systemic chemotherapies. * patients in part ii must have had one or two chemotherapy regimens for recurrent or metastatic disease exclusion criteria: * patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks * patient has not recovered from adverse events from previous therapy within 4 weeks * patient has received egfr-tki inhibitor/anti-egfr mab therapy * patient has received igf1r-tki inhibitor/anti-igf1r mab therapy * patient has untreated brain metastases * patient has had radiotherapy to a field that affects the chest or abdomen, or thoracic surgery within 3 months prior to entering the study * patient is taking part in another clinical study * patient abuses drugs or alcohol * patient is pregnant or breastfeeding * subject is hiv positive * patient has active hepatitis * patient is using growth hormone or growth hormone inhibitors * patient has poorly controlled diabetes mellitus
comparison of ondansetron, metoclopramide and promethazine for the treatment of nausea and vomiting in the adult ed

Conditions: Nausea

Summary: the purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population. we hypothesize that a single intravenous dose of ondansetron is more effective in reducing nausea than a single iv dose of metoclopramide, promethazine or normal saline placebo in undifferentiated adult emergency department patients.


Eligibility criteria:
inclusion criteria: * all patients age 18 or older who present to the ed with a complaint requiring antiemetic treatment who do not meet the exclusion criteria. exclusion criteria: * patients less than 18 years of age * unstable patients with sbp \< 90 * patients with a stated or documented allergy to any of the study medications * patients whose nausea rating if \< 40 on the pretreatment vas scale * patients who have received a commonly accepted antiemetic within the previous 24 hours * patients unwilling or unable to complete the assessment tool before and 30 minutes after study drug dosing
a controlled phase 2a study to evaluate the efficacy of edp-323 against respiratory syncytial virus infection in a virus challenge model

Conditions: RSV Infection

Summary: a randomized, phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered edp-323 in healthy subjects infected with rsv-a memphis 37b. this study is designed to assess the antiviral effect of edp-323 compared to a placebo control in the respiratory syncytial virus challenge model.


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * age 18 to 55 years, inclusive. * in good health with no history of major medical conditions. * a total body weight ≥ 50 kg and body mass index (bmi) ≥ 18 kg/m2 and ≤ 35kg/m2. exclusion criteria: * pregnant or nursing females * acute or chronic medical illness * history of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (urt or lrt) infection within 4 weeks prior to the first study visit. * abnormal lung function * positive for hiv, active hepatitis b or c test * nose or nasopharynx abnormalities * receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug

Keywords: challenge study rsv antiviral rsv-a memphis 37b
the reliability and validity of a smartphone app

Conditions: Rheumatoid Arthritis; Carpal Tunnel Syndrome

Summary: the goal of this observational study is to validate a smartphone app called angulus. the main question it aims to answer is: • is an angulus app valid and reliable system for masuring hand and wrist range of motion? participants will be evaluated by goniometers which is a gold standart for range of motion assessment.


Eligibility criteria:
inclusion criteria: * a history of previous traumatic hand or wrist injury in the upper extremity, * pain in the hand and wrist during evaluation * orthopedic, neurologic, or rheumatologic disease exclusion criteria: * not to understand the command that the therapist give

Keywords: reliability validity range of motion
evaluation of intervention on impaired glucose tolerance(igt) in patients with coronary heart disease.

Conditions: Coronary Heart Disease; Impaired Glucose Tolerance

Summary: the purpose of this study is to determine whether therapeutic intervention on impaired glucose tolerance in patients with coronary heart disease can decrease the incidence of new onset dm.


Eligibility criteria:
inclusion criteria: * patients with coronary heart disease * impaired glucose tolerance exclusion criteria: * age \ 75yr * diabetes mellitus * scr \> 2.0 mg/dl（176 μmol/l） * alt or ast \> 2.5 uln * hb \< 90g/l * heart failure * infection * undergo other interventional clinical trial
long-term performance and safety of biodentine™ in patients treated for endodontic indications

Conditions: Endodontically Treated Teeth

Summary: in this observational, retro-prospective, and multicenter pmcf clinical investigation, biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed: * repair of root or furcation perforations. * repair of root resorptions (internal and external). * root-end filling in endodontic surgery (retrograde filling). * apexification (tooth with open apex). * revitalization procedure by means of revascularization. evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.


Eligibility criteria:
inclusion criteria: * male or female, adult or child with permanent study tooth (immature or mature) * study tooth treated with an endodontic microsurgery using biodentine™: all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair and apexification * study tooth treated at least 1 year and no more than 5.5 years before inclusion visit * availability of baseline radiographic image of the study tooth * patient affiliated to national health insurance * patient informed about the study and who confirms his/her consent to participate to the study exclusion criteria: * patient treated with anti-cancer therapy in the 5 years prior to the treatment * uncontrolled systemic disease 1 month prior to the treatment * development of a cancer or a systemic disease just after the treatment * participation to an interventional clinical trial at the time of the treatment